Gursen Ceren, Meeus Mira, Verbeelen Kaat, Vets Nieke, Spincemaille Laura, Smeets Ann, Thomis Sarah, Fieuws Steffen, Vanderheyden Hans, Gebruers Nick, Tjalma Wiebren, Johansson Karin, Keeley Vaughan, De Groef An, Devoogdt Nele
Department of Rehabilitation Sciences and Physiotherapy, KU Leuven, Leuven, Belgium.
Faculty of Physical Therapy and Rehabilitation, Hacettepe University, Ankara, Turkey.
BMJ Open. 2025 Jun 8;15(6):e099990. doi: 10.1136/bmjopen-2025-099990.
Breast cancer-related lymphoedema (BCRL) at the arm and/or trunk/breast is a highly feared complication following breast cancer treatment and can be objectified using the state-of-the-art criteria based on volume, extracellular water ratio or skin thickness measurements. Although the incidence of objective BCRL is decreasing due to advances in breast cancer treatment, many patients report a sensation of swelling without the presence of objective BCRL, referred to as subjective BCRL. As little is known about the prevalence and the transitions between different BCRL states (no-subjective-objective) over time, as well as about the underlying mechanisms and contributing factors of subjective BCRL, this will be investigated in the LymphSens study.
230 patients with a new diagnosis of unilateral breast cancer will be included in a multicentre longitudinal study. Measurements are performed from presurgery to 12 months postsurgery. The primary objective (aim 1) is to determine the prevalence rate of subjective and objective BCRL at 1, 6 and 12 month(s) postsurgery, as well as transitions between BCRL states (no-subjective-objective BCRL) by a multinomial logistic regression model with generalised estimating equations and transition matrices, respectively. A second objective (aim 2) is to determine factors related to four potential underlying mechanisms (lymphatic, nociceptive, neuropathic and central sensory processing problems) that contribute to the occurrence of subjective BCRL in comparison with no self-reported swelling and objective BCRL. As a third objective (aim 3), within the group of patients with subjective BCRL, we will determine factors related to these four underlying mechanisms that contribute to the severity of subjective BCRL. The analyses for aim 2 and aim 3 will be conducted both at specific time points, that is, 1, 6 and 12 month(s) postsurgery using exploratory analysis and across all time points collectively using multivariable binary logistic regression models or multivariable longitudinal models for repeated measures.
The LymphSens study protocol received approval from the Ethics Committee of UZ Leuven (S68133) and UZ Antwerp/University of Antwerp (5676-003252). The results of the LymphSens study will be presented at conferences and published in peer-reviewed journals.
NCT06324721.
手臂和/或躯干/乳房处的乳腺癌相关淋巴水肿（BCRL）是乳腺癌治疗后令人高度恐惧的并发症，可依据基于体积、细胞外水比例或皮肤厚度测量的最新标准进行客观判定。尽管由于乳腺癌治疗的进展，客观BCRL的发病率在下降，但许多患者报告有肿胀感，却不存在客观BCRL，这被称为主观BCRL。由于对不同BCRL状态（无-主观-客观）随时间的患病率及转变情况，以及主观BCRL的潜在机制和促成因素知之甚少，因此将在LymphSens研究中对此进行调查。
230例新诊断为单侧乳腺癌的患者将纳入一项多中心纵向研究。测量从术前至术后12个月进行。主要目标（目标1）是通过分别使用广义估计方程的多项逻辑回归模型和转移矩阵，确定术后1、6和12个月时主观和客观BCRL的患病率，以及BCRL状态之间的转变（无-主观-客观BCRL）。第二个目标（目标2）是确定与四种潜在潜在机制（淋巴、伤害性、神经性和中枢感觉处理问题）相关的因素，这些因素与无自我报告肿胀和客观BCRL相比，促成了主观BCRL的发生。作为第三个目标（目标3），在主观BCRL患者组中，我们将确定与这四种潜在机制相关的因素，这些因素促成了主观BCRL的严重程度。目标2和目标3的分析将在特定时间点进行，即术后1、6和12个月使用探索性分析，并在所有时间点共同使用多变量二元逻辑回归模型或重复测量的多变量纵向模型。
LymphSens研究方案获得了鲁汶大学医院伦理委员会（S68133）和安特卫普大学医院/安特卫普大学（5676-003252）的批准。LymphSens研究的结果将在会议上展示并发表在同行评审期刊上。
NCT06324721。
